NEW YORK – ClearNote Health said Tuesday that it received approval from the New York State Department of Health Clinical Laboratory Evaluation Program for its epigenetic Avantect Pancreatic Cancer Test.
Avantect is designed to test for pancreatic cancer at its earliest stages by quantitatively analyzing cell-free DNA for the 5-hydroxymethylcytosine (5hmC) epigenetic biomarker, which has known associations with early cancer signals, and combining this data with other genomic information.
The liquid biopsy test is meant for high-risk patients, including those aged 50 years and older with type 2 diabetes, as well as individuals with a family history of pancreatic cancer and/or a known genetic predisposition.
The San Diego-based company, formerly known as Bluestar Genomics, began commercializing this test, along with one for ovarian cancer, in 2022. Additionally, the company's multi-cancer early detection test was recently included in the National Cancer Institute's Vanguard study.
"New York state is well known for its rigorous, patient-focused quality standards for laboratory-developed tests," ClearNote CEO Dave Mullarkey said in a statement. "This approval is another critical milestone for ClearNote Health, further validating our ongoing commitment to excellence in our tests and in our clinical laboratory services."